CAPRISA 004 Tenofovir Gel Trial
FHI 360 partnered with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) at the University of KwaZulu-Natal and with U.S.-based CONRAD to conduct the first study of the effectiveness of a microbicidal product containing an antiretroviral drug. CAPRISA 004, a Phase IIb, double-blind, randomized, placebo-controlled study, assessed the effectiveness and the safety of a vaginal gel containing 1% tenofovir for the prevention of HIV infection in South African women. Tenofovir is an antiretroviral drug that is widely used in the treatment of HIV. Results were announced at the XVIII International AIDS Conference in Vienna, Austria, on July 20, 2010.
Key results of CAPRISA 004
Tenofovir gel--used before and after sex--reduces HIV infections by 39 percent. Women who used the gel more often were up to 54 percent less likely to contract HIV.
Tenofovir gel--used before and after sex--reduces genital herpes infections by 51 percent.
Implications of CAPRISA 004
Tenofovir gel is an important new HIV prevention technology because, unlike other HIV prevention tools, it is controlled by the woman. That is significant because more than half of all new HIV infections worldwide occur in women and girls.
Tenofovir gel has the potential to have a huge impact on HIV prevention and to save millions of lives in the next two decades.
Results of CAPRISA 004 need independent scientific confirmation before tenofovir gel can achieve regulatory approval for public use.
The study was funded by the United States Agency for International Development (USAID) and the Technology Innovation Agency (TIA), a biotechnology agency of the South African government's Department of Science and Technology. In addition, Gilead Sciences provided tenofovir for the manufacture of the gel used in the study, and CONRAD manufactured and packaged the gels.
Through its USAID-funded Preventive Technologies Agreement (PTA) and Contraceptive and Reproductive Health Technologies Research and Utilization Program, FHI 360 provided the following technical assistance to the CAPRISA 004 trial:
- Protocol development
- Statistical design and analysis
- Behavioral research and design
- Evaluation of safety reports for trial participants
- Clinical monitoring and project management
- Ethical oversight and study safety oversight
- South Africa